iBTA Technology for Biomedical Applications

A special issue of Bioengineering (ISSN 2306-5354). This special issue belongs to the section "Regenerative Engineering".

Deadline for manuscript submissions: 30 September 2024 | Viewed by 1828

Special Issue Editor


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Guest Editor
Biotube Co., Ltd., Tokyo, Japan
Interests: regenerative medicine; tissue engineering; artificial blood vessels; biotube; biosheet; biovalve; allogeneic transplant; cardiovascular surgery; scaffolds; stem cells

Special Issue Information

Dear Colleagues,

Regenerative medicine is expected to be one of the next generation's major medical treatments. The goal of regenerative medicine approaches is to create biological therapies or substitutes to replace or restore the functions of living tissues lost due to failure or disease. Since general regenerative medicine requires the processing of cells or tissues, it will take time for it to become widely available, also for economic reasons. On the other hand, in-body tissue architecture (iBTA) technology, which uses the patient's body as an incubator to prepare tissues for autologous implantation, is a practical bioprocess engineering for regenerative medicine without requirement of any special equipment or facilities. By simply embedding a mold into the patient’s body temporarily, a personalized implant with the desired shape and dimensions can be almost automatically obtained using only the components within the patient's body. In recent years, it has become possible to collect stem cells in the body by applying iBTA. This Special Issue covers shape design for iBTA-based tissues, the evaluation of physical properties of their obtained tissue, application to various tissue regenerations, preclinical implant evaluation, and first-in-human clinical trials. By bringing together contributions from experts in a wide range of fields, the current state of iBTA technology will broadly introduce from basics to applications. 

Dr. Yasuhide Nakayama
Guest Editor

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Keywords

  • regenerative medicine
  • tissue engineering
  • artificial blood vessels
  • biotube
  • biosheet
  • biovalve
  • allogeneic transplant
  • cardiovascular surgery
  • scaffolds
  • stem cells
  • in-body tissue architecture (iBTA) technology

Published Papers (2 papers)

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16 pages, 13682 KiB  
Article
Carotid Artery Bypass Surgery of In-Body Tissue Architecture-Induced Small-Diameter Biotube in a Goat Model: A Pilot Study
by Tadashi Umeno, Kazuki Mori, Ryosuke Iwai, Takayuki Kawashima, Takashi Shuto, Yumiko Nakashima, Tsutomu Tajikawa, Yasuhide Nakayama and Shinji Miyamoto
Bioengineering 2024, 11(3), 203; https://doi.org/10.3390/bioengineering11030203 - 21 Feb 2024
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Abstract
Biotubes are autologous tubular tissues developed within a patient’s body through in-body tissue architecture, and they demonstrate high potential for early clinical application as a vascular replacement. In this pilot study, we used large animals to perform implantation experiments in preparation for preclinical [...] Read more.
Biotubes are autologous tubular tissues developed within a patient’s body through in-body tissue architecture, and they demonstrate high potential for early clinical application as a vascular replacement. In this pilot study, we used large animals to perform implantation experiments in preparation for preclinical testing of Biotube. The biological response after Biotube implantation was histologically evaluated. The designed Biotubes (length: 50 cm, internal diameter: 4 mm, and wall thickness: 0.85 mm) were obtained by embedding molds on the backs of six goats for a predetermined period (1–5 months). The same goats underwent bypass surgery on the carotid arteries using Biotubes (average length: 12 cm). After implantation, echocardiography was used to periodically monitor patency and blood flow velocity. The maximum observation period was 6 months, and tissue analysis was conducted after graft removal, including the anastomosis. All molds generated Biotubes that exceeded the tensile strength of normal goat carotid arteries, and eight randomly selected Biotubes were implanted. Thrombotic occlusion occurred immediately postoperatively (1 tube) if anticoagulation was insufficient, and two tubes, with insufficient Biotube strength (<5 N), were ruptured within a week. Five tubes maintained patency for >2 months without aneurysm formation. The spots far from the anastomosis became stenosed within 3 months (3 tubes) when Biotubes had a wide intensity distribution, but the shape of the remaining two tubes remained unchanged for 6 months. The entire length of the bypass region was walled with an αSMA-positive cell layer, and an endothelial cell layer covered most of the lumen at 2 months. Complete endothelial laying of the luminal surface was obtained at 3 months after implantation, and a vascular wall structure similar to that of native blood vessels was formed, which was maintained even at 6 months. The stenosis was indicated to be caused by fibrin adhesion on the luminal surface, migration of repair macrophages, and granulation formation due to the overproliferation of αSMA-positive fibroblasts. We revealed the importance of Biotubes that are homogeneous, demonstrate a tensile strength > 5 N, and are implanted under appropriate antithrombotic conditions to achieve long-term patency of Biotube. Further, we clarified the Biotube regeneration process and the mechanism of stenosis. Finally, we obtained the necessary conditions for a confirmatory implant study planned shortly. Full article
(This article belongs to the Special Issue iBTA Technology for Biomedical Applications)
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9 pages, 6626 KiB  
Case Report
Dramatic Wound Closing Effect of a Single Application of an iBTA-Induced Autologous Biosheet on Severe Diabetic Foot Ulcers Involving the Heel Area
by Ryuji Higashita, Yasuhide Nakayama, Manami Miyazaki, Yoko Yokawa, Ryosuke Iwai and Marina Funayama-Iwai
Bioengineering 2024, 11(5), 462; https://doi.org/10.3390/bioengineering11050462 - 6 May 2024
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Abstract
Introduction: Chronic wounds caused by diabetes or lower-extremity artery disease are intractable because the wound healing mechanism becomes ineffective due to the poor environment of the wound bed. Biosheets obtained using in-body tissue architecture (iBTA) are collagen-based membranous tissue created within the body [...] Read more.
Introduction: Chronic wounds caused by diabetes or lower-extremity artery disease are intractable because the wound healing mechanism becomes ineffective due to the poor environment of the wound bed. Biosheets obtained using in-body tissue architecture (iBTA) are collagen-based membranous tissue created within the body and which autologously contain various growth factors and somatic stem cells including SSEA4-posituve cells. When applied to a wound, granulation formation can be promoted and epithelialization may even be achieved. Herein, we report our clinical treatment experience with seven cases of intractable diabetic foot ulcers. Cases: Seven patients, from 46 to 93 years old, had large foot ulcers including in the heel area, which were failing to heal with standard wound treatment. Methods: Two or four Biosheet-forming molds were embedded subcutaneously in the chest or abdomen, and after 3 to 6 weeks, the molds were removed. Biosheets that formed inside the mold were obtained and applied directly to the wound surface. Results: In all cases, there were no problems with the mold’s embedding and removal procedures, and Biosheets were formed without any infection or inflammation during the embedding period. The Biosheets were simply applied to the wounds, and in all cases they adhered within one week, did not fall off, and became integrated with the wound surface. Complete wound closure was achieved within 8 weeks in two cases and within 5 months in two cases. One patient was lost due to infective endocarditis from septic colitis. One case required lower leg amputation due to wound recurrence, and one case achieved wound reduction and wound healing in approximately 9 months. Conclusions: Biosheets obtained via iBTA promoted wound healing and were extremely useful for intractable diabetic foot ulcers involving the heel area. Full article
(This article belongs to the Special Issue iBTA Technology for Biomedical Applications)
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